Alex Smith

Alex Smith

Hogan Lovells

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New FDA inspection program released for “streamlined approach” for combination product cGMP

On June 4, 2020, the U.S. Food and Drug Administration (FDA) updated the Compliance Program Guidance Manual (CPGM) to include a program for “Inspections of CDER-led or CDRH-led Combination Products.”...more

6/7/2020  /  CGMP , Drug Approvals , Food and Drug Administration (FDA) , Inspections , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements
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